Seagen

Principal Clinical Data Associate

Description

The Principal CDA is a Management-level CDA capable of leading Data Management aspects of a clinical study with minimal support and oversight. The Principal CDA has thorough knowledge of FDA regulations and industry standards, strong technical skills, and is capable of leading infrastructure assessment and improvement. This position may manage vendor/CRO relationships.

Principal Responsibilities:

• Independently lead all data management aspects of a clinical study, including on pivotal, blinded, and randomized trials
• Independently develop DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans. Demonstrate critical thinking, alignment-building and discretion to author documents that meet study needs
• Represent Data Management in governance bodies, product teams and cross-functional groups; lead internal working groups
• Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product. Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
• Adeptly run SAS programs, review SAS logs, and generate output. Program SAS Non-System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users as appropriate
• Independently lead data cleaning activities such as study team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation. Coordinate cross-functional input to drive creation of custom data review plans. Evaluate multiple options, exercise discretion and utilize experience to choose efficient and effective issues resolution paths
• Independently manage data deliverables processes and database locks in an efficient and timely manner
• Cultivate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.)
• DM Project Management: Understand critical tasks and milestones; ensure data management deliverables are met per study timelines. Utilize experience and appropriate tools to efficiently lead and coordinate data management activities. Ensure study team members understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct. Assist DM Management in coordinating and/or supervising data management activities across studies
• Research, evaluate and lead departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required
• Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring of junior CDAs and/or contractors; may manage CDAs
• Utilize experience and leadership skills to provide guidance to other team members
• Take ownership of procedures and resources available to team. Independently and collaboratively perform ongoing evaluation of procedures for efficiency and scalability

Qualifications:

• Years of experience: 8+ years
• Requires effective organizational and communication skills
• Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
• Detail oriented; performs quality and accurate work
• Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
• Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials
• Previous relevant EDC experience
• Previous vendor/CRO management

Preferred:

• Previous management experience is valued
• Previous experience with RTSM/IWRS and ePRO systems
• Database development experience
• SAS programming experience
• Oncology experience Education
• BA/BS in relevant field

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/08/2021